Specialty Process Labs
Form 483 issued November 19, 2021 · Phoenix, Arizona
- Inspection
- Nov 8 – Nov 19, 2021
- Investigator
- Christopher M. Jenner
- Observations
- 11
- Pages
- 7
- FEI number
- 3017888878
In short: On November 19, 2021, FDA issued a Form 483 with 11 observations to Specialty Process Labs in Phoenix, Arizona (FEI 3017888878) after an inspection that ran Nov 8 – Nov 19, 2021. The investigator was Christopher M. Jenner. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.68 (2×) · 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access…
- 02
Failure to appropriately qualify…
- 03
Failure to validate and monitor the (b) (4) to ensure (b)(4)…
- 04
Failure to establish written procedures to monitor the progress and control the performance of processing steps…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmSpecialty Process Labs history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Process Labs?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Specialty Process Labs?
Christopher M. Jenner is named on this Form 483, for the inspection of Nov 8 – Nov 19, 2021. Each investigator has a profile showing what they cite most.
When was Specialty Process Labs inspected by FDA?
The inspection ran Nov 8 – Nov 19, 2021, and the Form 483 is dated November 19, 2021.
How do I get the full Form 483 for Specialty Process Labs?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.